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NCT04142320 · ClinicalTrials.gov registry record · NA
Closed-loop Optimized rTMS for Depression
A NA study of Major Depressive Disorder, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT04142320: Recruiting NA study of Major Depressive Disorder, sponsored by Stanford University.
NCT04142320 is a NA study of Major Depressive Disorder that is actively recruiting participants, run by Stanford University. The registered enrollment target is 54 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04142320, a NA study of Major Depressive Disorder, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Targeted and individualized treatments for mental health disorders are critically needed. Repetitive transcranial magnetic stimulation (rTMS) represents the front-line of new and innovative approaches to normalizing dysfunctional brain networks in those with mental illness. rTMS is FDA-approved for depression and obsessive-compulsive disorder with clinical trials underway for PTSD and addiction, among others. However, remission rates are suboptimal and ideal stimulation parameters are unknown. We recently completed a randomized, double blind clinical trial and a depression severity biomarker that predicts clinical outcome. The overarching goal of this study is to develop the first broadly generalizable platform for real-time biomarker monitoring and personalized rTMS treatment. We plan to recruit patients with medication-resistant depression and in perform a four-phase, cross-over, double-blind, placebo-controlled trial to 1) identify how standard and optimized rTMS patterns engage the depression severity biomarker, and 2) determine the dose-response of these rTMS patterns. Findings from this study will provide the basis for a double-blind, randomized clinical trial comparing rTMS optimized to the individual against standard rTMS.
Primary Outcome
Change in TMS-EEG measures will be assessed before, during, and after each rTMS session. Specifically, the amplitude of the change 30ms after a single TMS pulse in the frontoparietal region will be quantified. Brain changes will be compared between closed- loop, open-loop, and sham rTMS to identify the location, strength, and dose response of change for each condition.
Conditions Studied
Interventions
- DEVICE sham rTMS
- DEVICE closed-loop rTMS
- DEVICE open-loop rTMS
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What NCT04142320 shows while recruiting
NCT04142320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which sham rTMS is the first listed.
NCT04142320 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04142320 about?
NCT04142320 is a clinical study titled "Closed-loop Optimized rTMS for Depression". Targeted and individualized treatments for mental health disorders are critically needed. Repetitive transcranial magnetic stimulation (rTMS) represents the front-line of new and innovative approaches to normalizing dysfunctional brain networks in those with mental illness. rTMS is FDA-approved for ...
What is the current status of trial NCT04142320?
This trial is currently recruiting. It is a NA study. The enrollment target is 54 participants. The study started on 2021-06-01. Estimated completion is 2025-12-01.
What conditions does trial NCT04142320 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04142320?
The interventions under investigation include: sham rTMS (DEVICE), closed-loop rTMS (DEVICE), open-loop rTMS (DEVICE).
Who is sponsoring clinical trial NCT04142320?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04142320 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04142320's enrollment target sits among peer trials
54 177th of 282 higher than 104 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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